Home GUDID 07290115935332 PER System 50
Primary DI 07290115935332
Brand PER System 50
Company PREMIA SPINE LTD
Model 89012
Device description PER System 50
Published 2024-10-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name NKB Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290115935332 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290115935332 07290115935332 7290115935332
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system rod An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 0 Percent (%) Relative Humidity 70 Percent (%) Relative Humidity Storage Environment Temperature 15 Degrees Celsius 22 Degrees Celsius
Regulatory Flags# DUNS number 649220779 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290115932492 Tower ST 88606 2026-06-01 07290115932751 Alignment Gauge Medium 86202 2026-06-01 07290115932898 Cannulated Screwdriver External sleeve 86513 2026-06-01 07290115934076 Tower ST Long Window 88974 2026-06-01 07290115935622 Cannulated Screwdriver Inner Shaft Short 88264 2026-06-01 07290115935639 Cannulated Screwdriver Handle Assy Short 88265 2026-06-01 07290115935646 Cannulated Screwdriver External sleeve Short 88266 2026-06-01 07290115935653 Cannulated Screwdriver Handle Assy XL 87245 2026-06-01 07290115935660 Cannulated Screwdriver Inner Shaft XL 87154 2026-06-01 07290115935837 MIS Tower Guide 86261N 2026-06-01 07290014381254 ProMIS™ Fixation System 87511 2026-05-25 07290014381261 ProMIS™ Fixation System 87512 2026-05-25 07290115935615 Counter Torque ST 83142N 2026-05-25 07290115932553 VersaLink Bender 82584 2024-10-01 07290115935479 Rod Bender 86297 2024-10-01 07290014381223 SST 316 LVM, L=470, Ø1.5 over the K-Wire 87851 2024-09-05 07290115934816 K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA 87302 2024-09-05 07290014381148 SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill 87447 2024-09-05 07290014381155 SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique 87209 2024-09-05 07290014381162 SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire 87208 2024-09-05
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